Q Series Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

CHISON MEDICAL IMAGING CO., LTD.

The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Q Series Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK153085
510k NumberK153085
Device Name:Q Series Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant CHISON MEDICAL IMAGING CO., LTD. NO.228, CHANGJIANG EAST ROAD, BLOCK 51 AND 53, PHASE 5 INDUSTRIAL PARK SHOUFA Wuxi,  CN 214142
ContactQifei Liu
CorrespondentBob Leiker
LEIKER REGULATORY & QUALITY CONSULTING 4157 North Del Rey Ave Clovis,  CA  93619
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-26
Decision Date2015-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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